Clinical Senior Quality Auditor

Location
Deerfield, IL, US;Homeworking
Salary
Competitive
Posted
18 Feb 2021
Closes
20 Mar 2021
Ref
2021-12850
Discipline
Quality, QA / QC
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
Overview

Advanced Clinical is a global clinical development organization that provides CRO, FSP, Quality & Validation, and Strategic Resourcing services for biopharmaceutical and medical device organizations. Our mission is to deliver a better clinical experience for our clients. With global experience in over 50 countries, we are committed to improving all lives touched by clinical research. We understand the complex nature of the clinical research industry and approach each opportunity with compassion. Together, we answer the hopes of patients and healthcare professionals with industry-leading services in global life-sciences. As part of the Advanced Group family of companies, Advanced Clinical employees provide the support, structure, and professional background and experience for better clinical trials and research. They are the foundation of our energetic and collaborative environment, where constant learning and service to others take top priority. We seek dynamic, hard-working team members who are inspired to work amongst diverse backgrounds and perspectives. From our altruistic mission to outstanding career development opportunities, there's no better place to grow your career than Advanced Clinical.

With direction and oversight from the Head of Compliance and Quality or designee, the Senior Quality Auditor is responsible for planning and conducting audits and other consulting services (gap assessments/analysis, inspection preparation, Standard Operating Procedure writing/revising, validation support, Quality Management Systems consulting, etc.) to our clients as assigned. The Senior Quality Auditor will support other staff as a co-auditor including reviewing/editing client deliverables, such as audit plans and reports. The Senior Quality Auditor may also be responsible for directing or mentoring applicable staff and/or contractors/consultants.

The Senior Auditor is a model of regulatory and quality systems compliance and should function as a subject matter expert and advisor to his or her colleagues throughout the organization.

Responsibilities

  • Planning, conducting, reporting, and documenting GxP audits on behalf of clients either in a sole, lead, or co-auditor capacity
  • Supporting other auditors and applicable staff by reviewing/editing client deliverables and internal documents
  • Providing other consulting services to clients as assigned
  • Updating applicable departmental trackers, as assigned
  • Maintaining GxP knowledge and expertise relevant to applicable local and international regulations
  • Providing direction to staff temporarily assigned to consulting service project or departmental initiatives
  • As needed and feasible (based on departmental workload), the Senior Quality Auditor will perform or assist with any other tasks, programs, initiatives, or assessments as assigned by Compliance and Quality management or applicable executives.

Qualifications

  • Bachelor's or equivalent degree in a relevant field of study (including but not limited to Quality, Business, Regulatory Affairs, Health Care, Research, etc.) is required. An advanced degree is preferred.
  • At least five years of experience in the GxP industry and a sound working knowledge of the pertinent regulations and have verifiable experience independently planning, conducting, and reporting quality assessments including audits
  • Training: Current documented training in GCP; additional documented training in either GMP or GLP preferred.
  • Certification: Has or will obtain within one year of hire at least one relevant certification (CQA, RQAP, RAC, etc.)
  • Candidate must demonstrate excellent writing skills, be an effective communicator (including public speaking), has exceptional organizational skills, ability to effectively perform independently in a remote setting, and be adept with applicable software systems.
  • Travel up to 50% may be required.
At Advanced Group, our commitment to diversity and inclusion in every part of our organization is crucial to fulfilling our mission and demonstrating our REAL values. A diverse staff allows us to effectively draw on different perspectives and enhance our efficiency and effectiveness. Diversity thereby strengthens the legitimacy and relevance of Advanced Group in delivering services to our clients. We seek talented, creative individuals from a variety of backgrounds and cultures to work with us. It is our priority that our workplace be inclusive, welcoming of diverse ideas and appreciative of valuable experience.

Equal Employment Opportunity

It is Advanced Group's practice not to discriminate against any Employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, physical or mental disability, medical condition, military or veteran status, or any other basis protected by applicable federal, state, or local law.

This practice applies to all terms and conditions of employment including, but not limited to, hiring, training, compensation, benefits, promotions, transfers, layoff, Company-sponsored education, social and recreational programs, and treatment on the job. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your Recruiter so that we can meet to discuss the appropriate alternatives available.

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